Quality Assurance

To ensure that instruments and supplies are sterile when used, monitoring of the
sterilization process is essential.

Administrative Monitoring

Work practices must be supervised. Written policies and procedures must be strictly
followed by all personnel responsible and accountable for sterilizing and disinfecting
items, and for handling sterile supplies. If sterility cannot be achieved or maintained,
the system has failed. Policies and procedures pertain to:

1. Decontaminating, terminally sterilizing, and cleaning all reusable items;

disposing of disposable items.
2. Packaging and labeling of items.
3. Loading and unloading the sterilizer.
4. Operating the sterilizer.
5. Monitoring and maintaining records of each cycle.
6. Adhering to safety precautions and preventive maintenance protocol.
7. Storing of sterile items.
8. Handling sterile items ready for use.
9. Making sterile transfer to a sterile field.

Mechanical Indicators

Sterilizers have gauges, thermometers, timers, recorders, and/or other devices that
monitor their functions. Most sterilizers have automatic controls and locking devices.
Some have alarm systems that are activated if the sterilizer fails to operate correctly.
Records are maintained and review for each cycle. Test packs (Bowie-Dick test) are
run at least daily to monitor functions of each sterilizer, as appropriate. These can
identify process errors in packing or loading.

Chemical Indicators

A chemical indicator on a package verifies exposure to a sterilization process. An

indicator should be clearly visible on the outside of every on-site sterilized package.
This helps differentiate sterilized from unsterilized items. More importantly, it helps
monitor physical conditions within the sterilizer to alert personnel if the process has
been inadequate. An indicator may be placed inside a package in a position most
likely to be difficult for the sterilant to penetrate. A chemical indicator can detect
sterilizer malfunction or human error in packaging or loading the sterilizer. If a
chemical reaction on the indicator does not show expected results, the item should
not be used. Several types of chemical indicators are available:

1. Tape, labels, and paper strips printed with an ink that changes color when
exposed to one or more process parameters.
2. Glass tube with pellets that melts when a specific temperature is attained in
sterilizer.
 3. Integrating or wicking paper with an ink or chemical tablet at one end that
melts and wicks along paper over time under desired process parameters.
The color bar reaches the "accept" area if parameters are met.

Biological Indicators

Positive assurance that sterilization conditions

have been achieved can be obtained only through a biologic control test. The
biologic indicator detects nonsterilizing conditions in the sterilizer. A biologic indicator
is a preparation of living spores resistant to the sterilizing agent. These may be
supplied in a self-contained system, in dry spore strips or discs in envelopes, or
sealed vials or ampoules of spores to be sterilized and a control that is not sterilized.
Some incorporate a chemical indicator also. The sterilized units and the control are
incubated for 24 hours for Bacillus stearothermophilis at 131 to 141°F (55 to 66°C) to
test steam under pressure, for 48 hours for Bacillus subtilis at 95 to 98.6°F (35 to
37°C) to test ethylene oxide.

A biologic indicator must conform with USP testing standards. A control test must be
performed at least weekly in each sterilizer. Many hospitals monitor on a daily basis;
others test each cycle. Very load of implantable devices must be monitored and the
implant should not be used until negative test results are known. Biological indicators
also are used as a challenge test before introducing new products or packaging
materials, after major repairs on the sterilizer, or after a sterilization failure. All test
results are filled as a permanent record for each sterilizer.